A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood

NCT05613777 | Completed Phase 1 Results

• 2 other identifiers: 1346-00362022-500050-42-00
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral contraceptive Microgynon®).

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

  This outcome measured the area under the concentration-time curve of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

  From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.

• Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

  This outcome measured the area under the concentration-time curve of levonogestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

  From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.

• Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)

  This outcome measured the maximum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

  From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.

• Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)

  This outcome measured the maximum measured concentration of levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

  From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.

• Minimum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )

  This outcome measured the minimum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

  From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.

• Minimum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss )

  This outcome measured the minimum measured concentration of Levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.

  From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21.

Study Arms (1)

Microgynon® (R), then Microgynon® + Iclepertin (T)

EXPERIMENTAL

Drug: Microgynon®; Drug: Iclepertin

Interventions

Iclepertin DRUG

Iclepertin

Also known as: BI 425809

Microgynon® (R), then Microgynon® + Iclepertin (T)

Microgynon® DRUG

ethinylestradiol (EE) and levonorgestrel (LNG)

Microgynon® (R), then Microgynon® + Iclepertin (T)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure(BP), Pulse rate (PR)), 12-lead Electrocardiogram (12-lead ECG), and clinical laboratory tests without any clinically significant abnormalities.
• Age of 18 to 35 years (inclusive).
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
• Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
• Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of BI 425809 and until 30 days after trial completion:
• Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom.
• Sexually abstinent.
• A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment).
• Surgically sterilised (including hysterectomy).

You may not qualify if:

• Subjects will not be allowed to participate, if any of the following general criteria apply:
• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Publications (1)

• Madari S, Balavarca Y, Shatillo Y, Reuteman-Fowler C, Desch M. The Effect of Multiple Oral Doses of a Glycine Transporter 1 Inhibitor, Iclepertin (BI 425809), on the Steady-state Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel: a Phase I Clinical Trial in Healthy Females. Clin Drug Investig. 2025 Oct;45(10):767-779. doi: 10.1007/s40261-025-01472-5. Epub 2025 Sep 4.

  PMID: 40906309 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

ethinyl estradiol, levonorgestrel drug combination; BI 425809

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fixed sequence: Run in period-Reference-Treatment

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: November 24, 2022
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)